(46 days)
Not Found
No
The summary describes a quality control material for coagulation assays, not a device that processes data or makes decisions using AI/ML. The performance studies focus on precision metrics of the control material itself.
No.
The device is described as a quality control for coagulation assays, not as a device used for treating or diagnosing a condition.
No
Explanation: The device is described as a "quality control" for coagulation assays. It is used to ensure the accuracy of diagnostic tests, not to diagnose a condition itself.
No
The device description explicitly states it is a "normal control prepared using human citrated plasma from healthy donors," indicating it is a biological material, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "quality control of coagulation assays." Quality control materials are used in vitro (outside the body) to verify the performance of diagnostic tests.
- Device Description: The description confirms it's a "normal control" prepared from human plasma, which is a biological sample used in laboratory testing.
- Performance Studies: The document includes performance studies (precision study) demonstrating how the control material performs when used with specific instruments and reagents for coagulation assays. This is typical for IVD devices.
- Predicate Device: The mention of a "Predicate Device" with a K number (K002400 Assess™ Normal Control) strongly indicates that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
Therefore, based on the provided information, the HemosIL Normal Control ASSAYED is clearly intended and used as an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HemosIL Normal Control ASSAYED is intended for the quality control of coagulation assays in the normal range on IL Coagulation and ELECTRA™ Systems. The normal control is prepared using human citrated plasma from healthy donors.
Product codes
81GGN
Device Description
HemosIL Normal Control ASSAYED is intended for the quality control of coagulation assays in the normal range on IL Coagulation and ELECTRA™ Systems. The normal control is prepared using human citrated plasma from healthy donors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
A precision study was performed with HemosIL Normal Control over multiple days with multiple runs using specific lots of IL reagents on IL instrumentation:
| Analyte | n= | Mean (n=80) | Within-Run %CV |
|---|---|---|---|
| Activated Partial Thromboplastin (APTT) (Seconds) | 80 | 28.0 | 1.87 |
| Antithrombin (% Activity) | 80 | 110 | 2.10 |
| Factor V (Extrinsic) (% Activity) | 80 | 96.4 | 4.47 |
| Factor VIII (Intrinsic) (% Activity) | 80 | 89.6 | 6.36 |
| Fibrinogen - Clauss (mg/dL) | 80 | 400 | 2.79 |
| Fibrinogen - PT-Based (mg/dL) | 80 | 329 | 4.62 |
| Plasmin Inhibitor (% Activity) | 40 | 99 | 1.05 |
| Plasminogen (% Activity) | 40 | 109 | 1.38 |
| Protein C (% Activity) | 80 | 114 | 2.98 |
| Protein S (% Activity) | 40 | 97.8 | 1.84 |
| Prothrombin Time (PT) (Seconds) | 80 | 10.1 | 1.58 |
| Thrombin Time (Seconds) | 80 | 13.0 | 1.54 |
Key Metrics
Mean and Within-Run %CV reported for various coagulation analytes as described in the Performance Studies section.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
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Section 3 HemosIL Normal Control - 510(k) Summary (Summary of Safety and Effectiveness)
Submitted by:
Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: 781-861-4467 Fax: 781-861-4207
Contact Person:
Carol Marble, Regulatory Affairs Manager Phone: 781-861-4467 / Fax: 781-861-4207
Summary Prepared:
March 28, 2002
Name of the Device(s):
HemosIL Normal Control ASSAYED
Classification Name(s):
| Common Name | Plasma Coagulation Control |
|---|---|
| Product Code | 81GGN |
| Regulation Number | 21 CFR 864.5425 |
| Classification | Class II |
Identification of Predicate Device(s):
K002400 Assess™ Normal Control NOTE: Control was 510(k) cleared as part of analyzer systems, most recently the ACL Advance.
Description of the Device/Intended Use(s):
HemosIL Normal Control ASSAYED is intended for the quality control of coagulation assays in the normal range on IL Coagulation and ELECTRA™ Systems. The normal control is prepared using human citrated plasma from healthy donors.
Statement of Technological Characteristics of the Device Compared to Predicate Device:
HemosIL Normal Control is substantially equivalent to the predicate device in performance, intended use and safety and effectiveness.
1
Section 3 (Cont.) HemosIL Normal Control - 510(k) Summary (Summary of Safety and Effectiveness)
Summary of Performance Data:
A precision study was performed with HemosIL Normal Control over multiple days with multiple runs using specific lots of IL reagents on IL instrumentation:
| Analyte | n= | Mean
(n=80) | Within-Run
%CV |
|------------------------------------------------------|----|----------------|-------------------|
| Activated Partial Thromboplastin (APTT)
(Seconds) | 80 | 28.0 | 1.87 |
| Antithrombin
(% Activity) | 80 | 110 | 2.10 |
| Factor V (Extrinsic)
(% Activity) | 80 | 96.4 | 4.47 |
| Factor VIII (Intrinsic)
(% Activity) | 80 | 89.6 | 6.36 |
| Fibrinogen - Clauss
(mg/dL) | 80 | 400 | 2.79 |
| Fibrinogen - PT-Based
(mg/dL) | 80 | 329 | 4.62 |
| Plasmin Inhibitor
(% Activity) | 40 | 99 | 1.05 |
| Plasminogen
(% Activity) | 40 | 109 | 1.38 |
| Protein C
(% Activity) | 80 | 114 | 2.98 |
| Protein S
(% Activity) | 40 | 97.8 | 1.84 |
| Prothrombin Time (PT)
(Seconds) | 80 | 10.1 | 1.58 |
| Thrombin Time
(Seconds) | 80 | 13.0 | 1.54 |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with three human profiles incorporated into its design, suggesting a connection between health, human services, and the nation.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Carol Marble Regulatory Affairs Manager Instrumentation Laboratory Company 101 Hartwell Avenue Lexington, Massachusetts 02421-3125
Re: K021023
Trade/Device Name: HemosIL Normal Control ASSAYED Regulation Number: 21 CFR § 864.5425 Regulation Name: Plasma, Coagulation Control Regulatory Class: II Product Code: GGN Dated: March 28, 2002 Received: March 29, 2002
Dear Ms. Marble:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the encreations of the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it 11 Jour de 100 to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r reaso o ac noved a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any 1 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
HemosIL Normal Control ASSAYED Device Names:
Indications for Use:
HemosIL Normal Control ASSAYED is intended for the quality control of coagulation assays in the normal range on IL Coagulation and ELECTRA™ Systems. The normal control is prepared using human citrated plasma from healthy donors.
Values for all analytes are within the normal range.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | (Division Sign-Off) | |
|---|---|---|
| Division of Clinical Laboratory Devices | ||
| 510(k) Number | K021023 | |
| Prescription Use | ||
| (Per 21 CFR 801.019) | OR | Over-The-Counter Use |
Section 2 HemosIL Normal Control 510(k) Page 1 of 1